Upper limb brace
by Shijiazhuang RunYi Medical Device Technology Co., ltd China EUDAMED
Ref P010Model lumbar support belt W2001,W2002,W2003,W2004,W2005,W2006,W2007,W2008,W2009,W2010,W2011,W2012,W2013,W2014,W2015,W2016,W2017,W2018,W2019,W2020,W2021,W2022,W2023,W2024,W2025 etc
EMDN Y060621
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697619156ULB01Q8 | Date11 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Upper limb brace
- Model / Reference
- lumbar support belt W2001, W2002, W2003, W2004, W2005, W2006, W2007, W2008, W2009, W2010, W2011, W2012, W2013, W2014, W2015, W2016, W2017, W2018, W2019, W2020, W2021, W2022, W2023, W2024, W2025 etc, P010
- Primary DI / UDI-DI
- 06976191565700
- Basic UDI-DI
- 697619156ULB01Q8
- EMDN Code
- Y060621 Shoulder orthoses
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000034467
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 16b917a6-27b6-4cdd-b6cf-113630e88959